Senior quality leader unifying Airbnb’s multilingual Community Support QA programs. Driving AI - enabled quality measurement, operational improvements, and global partner performance from Canada.
About the role
- Global Study Manager leading clinical trial execution, CRO oversight, vendors, budgets, and inspection readiness at Parexel. Remote role based in Ontario, Canada.
Responsibilities
- Lead and coordinate global clinical trial execution from sourcing strategy and study specification through study startup, database release, and inspection readiness
- Oversee study management, site management, CRO, and vendor deliverables throughout the study lifecycle
- Coordinate regional and country operations and provide oversight of Study Operational Managers and CRO activities
- Set recruitment targets and delivery milestones and ensure execution against approved plans
- Serve as a core study team member and represent the operational sub-team
- Drive operational decision-making and provide input into operational strategy and protocol design
- Supervise and mentor Study Operational Managers and potentially other Global Study Managers
- Develop, review, and approve study startup, monitoring, recruitment, training, and other study-level plans
- Oversee drug supply management and interactive randomization system setup
- Manage vendor oversight, escalations, budgets, contracts, invoices, purchase orders, and cost variance
- Review feasibility and pre-trial assessment outputs, approve sites, and assess site activation plans
- Ensure Trial Master File setup and applicable system closure
- Coordinate study and protocol training and global investigator meetings
- Lead inspection readiness and site readiness activities
- Support decentralized capabilities at investigator sites
- Review study metrics, analytics, data reports, and dashboards to identify and mitigate risks
- Resolve or triage site-level issues with cross-functional teams and CROs
- Ensure compliance with SOPs, quality standards, GCPs, and study plans
- Partner with data management and other departments to ensure data flow and timely delivery
- Lead protocol deviation trend reviews and facilitate vendor calls
- Serve as a technical expert for study management systems and processes
- Champion harmonized processes, continuous improvement, quality assurance, and timely clinical trial data delivery
- Identify and resolve operational staff performance issues
- Support project-specific audits and inspections
Requirements
- Experience in clinical research and/or study management
- Study management/leadership experience
- Experience with oversight of CROs and vendors
- Experience managing per-subject costs, vendor and ancillary costs, monitoring cost projections, and spend
- Fluency in written and spoken English required
- Ability to work outside core business hours to support global trials or initiatives
- Ability to travel as required, including investigator meetings, vendor kick-off and re-set meetings, and client internal global or department-level meetings
- Exceptional knowledge of study management processes and deliverables
- Good understanding of responsibilities beyond the candidate’s function to ensure study goals are met
- Expertise within the assigned therapeutic area and study
- Working knowledge of Good Clinical Practices (GCPs), monitoring, clinical operations, and regulatory operations
- Bachelor of Science or Bachelor of Arts degree with a minimum 7 years of relevant operational clinical trial experience in a CRO or pharma setting required
- Alternatively, Master of Science or Master of Business Administration degree with a minimum 6 years of relevant operational clinical trial experience in a CRO or pharma setting required
- Scientific or technical degree preferred
- Advanced knowledge of own discipline and knowledge of related disciplines
Benefits
- Full-time employment
- Remote work arrangement
- Opportunity to contribute to therapies that benefit patients
- Potential travel to investigator meetings, vendor meetings, and client global or department meetings
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Remote Personal Care Specialist guiding patients through reimbursement, copay management, and pharmacy coordination. Supporting medication access for Cencora’s healthcare programs from a home office.
Senior Manager creating social, influencer, and CTV campaigns for Later’s AI - powered influencer marketing platform. Developing concepts, scripts, storyboards, and creative direction for brands.
Marketplace performance intelligence manager at Achievers, whose platform powers employee recognition and rewards. Leading analytics, KPI governance, executive insights and performance improvement across the marketplace.
Model Validation Manager validating credit and treasury risk models at EQ Bank, Canada’s challenger bank. Preparing validation reports and supporting model risk governance.
Registration and Licensing Manager at Sun Life, helping financial advisors meet securities, mutual fund, and insurance requirements. Managing licensing operations, regulatory support, reporting, and continuous process improvement.
Senior Manager leading oncology market access and government affairs across Quebec and Atlantic Canada. Advancing reimbursement, policy strategy, and stakeholder partnerships for AbbVie’s innovative medicines.
Senior Manager leading AbbVie’s oncology market access and government affairs across Quebec and Atlantic Canada. Advancing reimbursement, policy, and stakeholder strategies with Canadian healthcare decision - makers.
Chef principal chez AbbVie, dirigeant les affaires gouvernementales et l’accès au marché des traitements oncologiques. Influence les politiques et remboursements au Québec et au Canada atlantique.
General Management Support Manager coordinating caisse strategy, HR, communications and budgets at Desjardins. Supporting executive governance, talent development, labor relations and community representation.